SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

NCT05476107 | Completed Phase 1 DMC

• 2 other identifiers: AMT-126-0012020-005779-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-emergent adverse events (safety and tolerability)

  Single ascending doses of AMT-126 in healthy adult volunteers by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v5.0

  5 days

• To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)

  Qualitative scintigraphic data will be compiled using the following data points for analysis: tablet release (hh:mm), location of tablet release (anatomical location), gastric emptying and arrival times (hh:mm)

  5 days

Secondary Outcomes (1)

• To assess pharmacokinetics of AMT-126 in healthy volunteers

  5 days

Study Arms (3)

AMT-126

EXPERIMENTAL

oral AMT-126

Drug: AMT-126

Placebo

PLACEBO COMPARATOR

oral placebo

Drug: Placebo

Radioactive Tablet (Part 2 only)

OTHER

oral radioactive tablet for scintigraphic analysis

Other: Radioactive Tablet (Part 2 Only)

Interventions

AMT-126 DRUG

Single or daily dosing at doses A, B, C, D, E, F; G, H, and I

Also known as: no other name applicable

AMT-126

Placebo DRUG

Single or daily dosing at doses A, B, C, D, E, F; G,H, and I

Also known as: no other name applicable

Placebo

Radioactive Tablet (Part 2 Only) OTHER

Single dose in two periods in Part 2 (optional)

Also known as: no other name applicable

Radioactive Tablet (Part 2 only)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects and female subjects of NOCBP.
• Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
• A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
• Contraception requirements for male \& female subjects.

You may not qualify if:

• Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
• Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
• Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
• Evidence of current SARS-CoV-2 or COVID infection.
• Women of child-bearing potential.

Sponsors & Collaborators

• Applied Molecular Transport: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Radioactivity

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded (Part 1), Open Label (Part 2)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 27, 2022
• Study Start: February 26, 2021
• Primary Completion: March 26, 2022
• Study Completion: March 26, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)